Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Collaborators: PKUcare luzhong hospital; Taierzhuang District People's Hospital; Yuncheng Hospital of Traditional Chinese Medicine; Zhengzhou Central Hospital; Zibo Central Hospital
• Treatments: Amoxicillin; Bismuth; Esomeprazole; Potassium Citrate; Tetracycline

Criteria

Inclusion Criteria:

• Patients aged 18-65.

• Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).

• Patients who have never received H. pylori eradication treatment.

Exclusion Criteria:

• Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.

• Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.

• Patients with active gastrointestinal bleeding.

• Patients with a history of upper gastrointestinal surgery.

• Patients allergic to treatment drugs.

• Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks

• Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse

• Patients who are unwilling or incapable to provide informed consents.